GXO
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Strip, Craniosynostosis, Preformed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5900
- Medical specialty
- Neurology
- Flags
- Implant
- Adverse events (MAUDE)
- 2003: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1 (K033395) | Codman & Shurtleff, Inc. | 2004-02-25 |
| PRECLUDE SYNBLOC MEMBRANE (K961802) | W. L. Gore & Associates, Inc. | 1996-07-31 |
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Every clearance here is in the API, with alerts when new ones post.